Real World Evidence Conference

For certain clinical settings and scenarios, randomized control trials (RCTs) may be unethical or operationally infeasible. The use of real world data/evidence may provide additional context and supplementary evidence to support regulatory decisions and may be warranted due to the rarity of the disease, scarcity of patients, scientific concerns with data interpretability, or ethical considerations. This session will 1) discuss drug development scenarios that may benefit from the use of real world evidence specifically external comparators, also called synthetic, historical or virtual controls, that supplement or augment RCT data; 2) identify perceived barriers to the use and methodological approaches for constructing external comparator arms; and 3) describe use cases and operational considerations.